Who is the manufacturer of Bluebird Single-Use Respiratory Effort Belt?

Cadwell Industries, Inc. filed the 510(k) submission for Bluebird Single-Use Respiratory Effort Belt (K242424).

What is the FDA product code for Bluebird Single-Use Respiratory Effort Belt?

MNR. It is classified under 21 CFR 868.2375 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for Bluebird Single-Use Respiratory Effort Belt?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Bluebird Single-Use Respiratory Effort Belt?

XactTrace® Single Use Respiratory Effort Belt System (K173793).

Who can help prepare an FDA 510(k) submission like Bluebird Single-Use Respiratory Effort Belt?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Bluebird Single-Use Respiratory Effort Belt

K242424 · Cadwell Industries, Inc. · MNR · Dec 18, 2024 · Anesthesiology

Device Facts

Record ID	K242424
Device Name	Bluebird Single-Use Respiratory Effort Belt
Applicant	Cadwell Industries, Inc.
Product Code	MNR · Anesthesiology
Decision Date	Dec 18, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.2375
Device Class	Class 2
Attributes	Pediatric

Intended Use

The Bluebird Single-Use Respiratory Effort Belt is intended to measure respiratory effort to assist in the diagnosis of sleep disorders or sleep related respiratory disorders. The respiratory effort belt signals are suitable for connection to sleep/polysomnography (PSG) systems. The intended environments are hospitals, institutions, sleep clinics, or other test environments, including the patient's home. The Bluebird Single-Use Respiratory Effort Belt is intended for diagnostic purposes only on patients greater than 2 years of age and is not intended to be used as an apnea monitor.

Device Story

Bluebird Single-Use Respiratory Effort Belt measures chest/abdomen expansion/contraction during respiration; utilizes Respiratory Inductive Plethysmography (RIP) technology. Device consists of elastic belt with embedded sinusoidal copper wire coil; inductance changes as belt stretches. Connects to physiological recording equipment (PSG systems) via 1.5mm female touch-proof jacks. Used in hospitals, clinics, or home settings; operated by clinicians or technicians. Provides output signal proportional to stretch; assists clinicians in diagnosing sleep disorders. Passive device; no internal power source; signal processing performed by connected PSG recorder.

Clinical Evidence

Bench testing only. Comparative performance testing demonstrated equivalent respiratory effort signal output between the subject device and the predicate when connected to the same PSG recorder. Testing verified dimensional requirements, buckle functionality, and compatibility with standard PSG recording equipment.

Technological Characteristics

Respiratory Inductive Plethysmography (RIP) sensor. Materials: elastic fabric, plastic (polypropylene buckle), copper wire. Form factor: pre-sized elastic belt (various sizes). Connectivity: 1.5mm female touch-proof jacks (DIN 42 802 compliant). Passive device; no energy source. Single-use.

Indications for Use

Indicated for patients > 2 years of age to measure respiratory effort for diagnosis of sleep disorders or sleep-related respiratory disorders. Not for use as an apnea monitor.

Regulatory Classification

Identification

A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.

Predicate Devices

XactTrace® Single Use Respiratory Effort Belt System (K173793)

Reference Devices

Nox RIP Belts and Nox RIP Belt Cables (K151361)

Related Devices

K173793 — XactTrace Single Use Respiratory Effort Belt System · Embla Systems · Mar 1, 2019
K151361 — Nox RIP Belts & Cables · Nox Medical Ehf · Nov 6, 2015
K043132 — UNIVERSAL XACTTRACE · Medcare Flaga · Dec 21, 2004
K171304 — Maxxi Rip Sensor · Neurovirtual USA, Inc. · Jun 24, 2019
K983449 — GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR · Gereonics, Inc. · Feb 8, 1999

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font. December 18, 2024 Cadwell Industries, Inc. Jason Ford Regulatory Affairs Manager 909 North Kellogg St. Kennewick, Washington 99336 Re: K242424 Trade/Device Name: Bluebird Single-Use Respiratory Effort Belt Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: MNR Dated: November 15, 2024 Received: November 15, 2024 Dear Jason Ford: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" {1}------------------------------------------------ (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). {2}------------------------------------------------ Sincerely, ### Rachana Visaria -S Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K242424 Device Name Bluebird Single-Use Respiratory Effort Belt #### Indications for Use (Describe) The Bluebird Single-Use Respiratory Effort Belt is intended to measure respiratory effort to assist in the diagnosis of sleep disorders or sleep related respiratory disorders. The respiratory effort belt signals are suitable for connection to sleep/polysomnography (PSG) systems. The intended environments are hospitals, institutions, sleep clinics, or other test environments, including the patient's home. The Bluebird Single-Use Respiratory Effort Belt is intended for diagnostic purposes only on patients greater than 2 years of age and is not intended to be used as an apnea monitor. Type of Use (Select one or both, as applicable) | <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | |------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------| |------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------| #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ ### K242424 510(k) Summary #### Submitter Information | Submitter Name: | Cadwell Industries, Inc. | |------------------------|-----------------------------| | | 909 N. Kellogg Street | | | Kennewick, Washington 99336 | | Submitter Phone: | 509-735-6481 | | Contact Person: | Jason Ford | | | Regulatory Affairs Manager | | Date Summary Prepared: | November 15, 2024 | | Subject Device | | Trade Name: Common Name: Classification Name: Bluebird Single-Use Respiratory Effort Belt Respiratory Effort Sensor 21 CFR 868.2375. Ventilatory Effort Recorder, Breathing Frequency Monitor Class II MNR ### Product Code: #### Predicate Device 510(k) Number: Trade Name: Submitter Name: Classification Name: Product Code: K173793 XactTrace® Single Use Respiratory Effort Belt System Natus Neurology 21 CFR 868.2375, Breathing Frequency Monitor MNR #### Reference Predicate Device | 510(k) Number: | K151361 | |----------------------|----------------------------------------------| | Trade Name: | Nox RIP Belts and Nox RIP Belt Cables | | Submitter Name: | Nox Medical | | Classification Name: | 21 CFR 868.2375, Breathing Frequency Monitor | | Product Code: | MNR | #### Device Description The Bluebird Single-Use Respiratory Effort Belt (Bluebird) is used to measure chest and abdomen expansion and contraction during respiration. The sensor consists of a sinusoidal wire coil attached along the length of an elastic belt. The inductance of the sensor changes as the belt is stretched. The Bluebird is suitable for connection to the inputs of physiological recording equipment. The Bluebird measures inductance and generates an output signal proportional to the amount of stretch. The elastic belt is held in place by a quick release buckle with a cinch function and the belt is adjusted to fit snugly but comfortably. Electrical connection to the two ends of the embedded coil is through a 1.5mm female touch proof connection jack on each side of belt buckle. The materials are elastics and plastics used in the clothing industry, and fine gauge copper wire for the embedded coil. {5}------------------------------------------------ ## VELL K242424 510(k) Summary #### Indications for Use The Bluebird Single-Use Respiratory Effort Belt is intended to measure respiratory effort to assist in the diagnosis of sleep disorders or sleep related respiratory disorders. The respiratory effort belt signals are suitable for connection to sleep/polysomnography (PSG) systems. The intended environments are hospitals, institutions, sleep clinics, or other test environments, including the patient's home. The Bluebird Single-Use Respiratory Effort Belt is intended for diagnostic purposes only on patients greater than 2 years of age and is not intended to be used as an apnea monitor. #### Summary of Technological Characteristics and Comparison to the predicate device The Bluebird employs the same technological characteristics as the predicate device. The following table provides a side-by-side comparison of the Indications for Use and technological characteristics of the subject and predicate devices. | Feature | XactTrace Single-Use Respiratory Effort Belt System (Predicate K173793) | Bluebird Single-Use Respiratory Effort Belt (Subject Device) | Equivalence Comments, Discussion | |-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | The XactTrace® Single Use Respiratory Effort Belt System is intended to measure respiratory effort to assist in the diagnosis of sleep disorders or sleep related respiratory disorders. The respiratory effort signals measured are processed to provide electrical signals suitable for connection to the inputs of physiological recording equipment. The intended environments are hospitals, institutions, sleep centers, sleep clinics. The XactTrace Single Use Respiratory Effort Belt System is intended for diagnostics purposes only and is not intended to be used as an apnea monitor. | The Bluebird Single-Use Respiratory Effort Belt is intended to measure respiratory effort to assist in the diagnosis of sleep disorders or sleep related respiratory disorders. The respiratory effort belt signals are suitable for connection to sleep/polysomnography (PSG) systems. The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments, including the patient's home. The Bluebird Single-Use Respiratory Effort Belt is intended for diagnostic purposes only on patients greater than 2 years of age and is not intended to be used as an apnea monitor. | There are no significant differences in the indications for use between the subject and predicate device. The specific use for patients 2 years and older is the same as found in the reference device, K151361. | | Population of use | Adult and pediatric | greater than 2 years of age | No significant differences, see above comment to reference predicate. | | Environment of Use | Hospitals, institutions, sleep centers, sleep clinics or other test environments, including the patient's home. | Hospitals, institutions, sleep centers, sleep clinics, or other test environments, including the patient's home. | Equivalent | | Single patient use | Yes | Yes | Equivalent | | Duration of use | Duration of clinical uses, anticipated to be ≤ 12 hours. | Duration of clinical uses, anticipated to be ≤ 12 hours. | Equivalent | | Fundamental technology | Respiratory Inductive Plethysmography (RIP) | Respiratory Inductive Plethysmography (RIP) | Equivalent | | Compatible recording technology | Physiological recording equipment | Physiological recording equipment | Equivalent | | Belt Length Variations | Pre-sized | Pre - sized | Equivalent | | Patient applied location | Abdomen and Thorax | Abdomen and Thorax | Equivalent | | Pre-Sized Belt Sizes (Circumference) | Pre-sized variations of large, medium, small and pediatric (inches). Large: 40 to 75 Medium: 30 to 55 Small: 16 to 35 Pediatric: 11 to 22 | Pre-sized variations of large, medium, small and pediatric (inches). Large: 40 to 75 Medium: 30 to 55 Small: 16 to 35 Pediatric: 11 to 22 | Equivalent | | Patient contact | Not in direct contact with bare skin. | Not in direct contact with bare skin. | Equivalent | | Belt connectors | Touchproof safety connection, complying with DIN 42 802 for Touchproof connection systems. | Touchproof safety connection, complying with DIN 42 802 for Touchproof connection systems. | Equivalent | | Belt Material | Elastic Band with Wire | Elastic Band with Wire | Equivalent | | Buckle Material | ABS | Polypropylene | Equivalent. Both materials are commonly used for plastic mold injection during the manufacturing process. The differences in material do not affect the safety or efficacy of the device. | | Performance Testing | Dimensional requirements Buckle functionality Compatibility with a PSG recorder Equivalence of breathing effort signal output | Dimensional requirements Buckle functionality Compatibility with a PSG recorder Equivalence of breathing effort signal output | The performance testing for the subject device are equivalent to the predicate within the characteristics of Dimensional requirements, Buckle functionality, Compatibility with a PSG recorder and equivalency of breathing signal output. | {6}------------------------------------------------ # / 日_ K242424 510(k) Summary {7}------------------------------------------------ ## K242424 510(k) Summary humidity Resistance EMC compliance Cleaning is not required since the subject device is a single use device. EMC and operational testing is not required for the subject device and is mitigated by the PSG recording device requirements. Therefore, these differences do not affect the safety or efficacy of the subject device. #### Performance Testing Nonclinical tests were performed on the subject device in order to show the technological equivalency to the predicate device and to verify the compliance to design requirements. No special controls exist for this type of device. Device testing included dimensional requirements, continuity. belt buckle function, ability to connect the subject device to a standard PSG recording device, recorded respiratory effort signal quality, packaging testing and comparative performance testing to the predicate. The comparative performance testing provided direct performance comparison to the actual recorded output signal of each device. Performance testing was performed for the Bluebird rip belt connected to a Cadwell recording device and simultaneously to an XactTrace belt, therefore both belts acting as passive devices, connected to the same Cadwell PSG recorder. The resulting waveforms are the same for both belts. #### Conclusion The passing results of the nonclinical tests and the technological and Indications for Use comparison demonstrate the Bluebird Single-Use Respiratory Effort Belt is substantially equivalent to the legally marketed predicate device.